Over-the-counter drug · ANDA
Eye Allergy Itch Relief Once Daily Relief (Olopatadine hydrochloride ophthalmic) NDC 43598-827
Olopatadine hydrochloride 2 mg/mL · Solution · Ophthalmic · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)43598-827Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0827Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-827-02 | 4359808270243598082702 | 1 BOTTLE, PLASTIC in 1 CARTON (43598-827-02) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Oct 1, 2020 | |
| 43598-827-25 | 4359808272543598082725 | 2 BOTTLE, PLASTIC in 1 CARTON (43598-827-25) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Oct 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eye Allergy Itch Relief Once Daily ReliefSuffix: Once Daily Relief
- Generic name (nonproprietary)
- olopatadine hydrochloride ophthalmic
- Active ingredients
- Olopatadine hydrochloride — 2 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Dr. Reddy's Laboratories Inc.NDC labeler code 43598
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209752
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43598-827_8a130978-3a2c-2fe5-ba95-8b008140068dSPL ID 8a130978-3a2c-2fe5-ba95-8b008140068dSPL set ID d9a01be0-218b-b2b9-1cbf-14a9c160ceb2RxCUI 1111343UNII 2XG66W44KF
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443598082702followed by a unit qualifier and the quantityPackage 43598-0827-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
USE temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 43598-827
- What is NDC 43598-827?
- 43598-827 is the product NDC for Eye Allergy Itch Relief Once Daily Relief, Olopatadine hydrochloride 2 mg/mL solution, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eye Allergy Itch Relief Once Daily Relief (Olopatadine Hydrochloride Ophthalmic).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eye Allergy Itch Relief Once Daily Relief?
- 1 other product NDC are listed under this name. See all Eye Allergy Itch Relief Once Daily Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eye Allergy Itch Relief Once Daily Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Strategic Sourcing Services LLC | 70677-1155 | 70677-1155-01 |
Other NDCs under ANDA 209752
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Allergy Relief Eye Dropsolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-675 |
| CVS Eye Allergy Itch Relief Once Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | CVS Health Corp | 69842-269 |
| Eye Allergy Itch Reliefolopatadine hcl | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0053 |
| Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Strategic Sourcing Services LLC | 70677-1155 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | Rugby Laboratories | 0536-1307 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Walgreens Company | 0363-7131 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Target Corporation | 11673-688 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Rite Aid Corporation | 11822-9975 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Albertsons Companies | 21130-105 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 63868-821 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Gland Pharma Limited | 68083-231 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 83324-120 |
| Olopatadine Hydrochloride Ophthalmic Solution Once Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | DOLGENCORP, LLC | 55910-137 |
| Once Daily Reliefolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | H E B | 37808-045 |